Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
1
Countries
1
Sites
1
inflammatory rheumatic diseases (IRD): rheumatoid arthritis (RA), SLE, spondylarthropathies, psoriatic arthritis, systemic vasculitis or systemic sclerosis
Key facts
- Sponsor
- Region Skane Skanes Universitetssjukhus, Region Skane Skanes Universitetssjukhus
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02], Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 17 Dec 2024 → ongoing
- Decision date (initial)
- 2023-11-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
inflammatory rheumatic diseases (IRD): rheumatoid arthritis (RA), SLE, spondylarthropathies, psoriatic arthritis, systemic vasculitis or systemic sclerosis
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Skane Skanes Universitetssjukhus
- Sponsor organisation
- Region Skane Skanes Universitetssjukhus
- Address
- Entregatan 7, Lunds Allhelgonafors Lunds Allhelgonafors
- City
- Lund
- Postcode
- 222 42
- Country
- Sweden
Scientific contact point
- Organisation
- Region Skane Skanes Universitetssjukhus
- Contact name
- Reumatologkliniken i Lund, Jehns Christian Martineus, sektionschef
Public contact point
- Organisation
- Region Skane Skanes Universitetssjukhus
- Contact name
- Reumatologkliniken i Lund, Jehns Christian Martineus, sektionschef
Region Skane Skanes Universitetssjukhus
- Sponsor organisation
- Region Skane Skanes Universitetssjukhus
- Address
- Entregatan 7
- City
- Lund
- Postcode
- 222 42
- Country
- Sweden
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 1 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Sweden | 2024-12-17 | 2024-12-17 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-23 | Sweden | Acceptable 2023-10-31
|
2023-11-06 |